Posts in Clinical Trials
Amivantamab With Tyrosine Kinase Inhibitors (TKIs) for Advanced NSCLC With ALK, ROS1, or RET Alterations
Amivantamab With Tyrosine Kinase Inhibitors (TKIs) for Advanced NSCLC With ALK, ROS1, or RET Alterations

Who is this trial for: This trial is for patients with one of three forms of non-small cell lung cancer (NSCLC) – ALK, ROS1, or RET - who are progressing on their current TKI under certain conditions, and are willing to try an experimental drug combination in order to extend the life of their current TKI.  Amivantamab is a bi-specific antibody targeting the cell survival pathways MET and EGFR.  The trial may be most appropriate for patients who are progressing without a targetable mutation or clearly identified driver of their cancer growth.

 

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Clinical TrialsKirk SmithClinical Trials, Amivantamab, Dr. Tejas Patil
Phase II Clinical Trial NCT05384626 by Nuvalent, Inc. A Study of NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Phase II Clinical Trial NCT05384626 by Nuvalent, Inc. A Study of NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

Who is this trial for: NVL-655 is a 4th generation, brain-penetrant, ALK TKI inhibitor created to overcome several limitations observed with currently available therapies. NVL-655 is designed to have activity in tumors that have developed resistance to first, second, and third-generation ALK inhibitors, including tumors with the solvent front G1202R mutation or compound mutations G1202R/L1196M (“GRLM”), G1202R/G1269A (“GRGA”), or G1202R/L1198F (“GRLF”).  In other words, it is for patients for whom other ALK TKIs have failed under certain conditions. 

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Clinical TrialsKirk SmithClinical Trials, Nuvalent, NVL-655, ALKOVE-1
ALKOVE-1 Study Results Summary: NVL-655’s Promising Role in Treating Advanced ALK+ Lung Cancer
ALKOVE-1 Study Results Summary: NVL-655’s Promising Role in Treating Advanced ALK+ Lung Cancer

The clinical results from the Phase 1 portion of the ALKOVE-1 study is bringing new hope to patients with ALK-positive lung cancer, especially those who have exhausted other treatment options. NVL-655, a fourth-generation ALK inhibitor, has shown unique effectiveness in overcoming resistance to previous treatments, including those with brain metastases and specific resistance mutations

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Clinical TrialsKirk SmithClinical Trials, ALKove-1, NVL-655
ALK Clinical Trials September 2024: Should Brain Metastases be Treated with Radiation at Diagnosis in ALK+ Lung Cancer? Research About a Crucial Question
ALK Clinical Trials September 2024: Should Brain Metastases be Treated with Radiation at Diagnosis in ALK+ Lung Cancer? Research About a Crucial Question

For those facing the challenging diagnosis of ALK-positive lung cancer, brain metastases often pose a serious concern. Research reveals that up to 40% of these patients have brain metastases right from the start. This sets the stage for a critical question in treatment planning: Is it better to tackle these brain metastases with spot radiation, or stereotactic radiosurgery (SRS)

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Clinical TrialsKirk SmithClinical Trials, Radiation, Brain Metastases
Discovering Insights Beyond Clinical Trials: Exploring ALK-Positive Lung Cancer Treatment
Discovering Insights Beyond Clinical Trials: Exploring ALK-Positive Lung Cancer Treatment

Clinical trials are the gold standard for evaluating new treatments in medicine. They offer a structured approach, where patient groups are carefully selected, treatments are administered, and results are meticulously followed over time. This controlled environment allows for a deep understanding of how treatments perform in specific patient populations, free from the confounding factors that might skew results.

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Clinical TrialsKirk SmithClinical Trials
Gilteritinib for the Treatment of ALK positive non-small cell lung cancer (NSCLC
Gilteritinib for the Treatment of ALK positive non-small cell lung cancer (NSCLC

This trial is for patients with Stage 4 ALK positive NSCLC that have progressed on an earlier generation ALK TKI AND lorlatinib, and on any number of other standard-of-care or trial treatments. The trial drug is gilteritinib (aka Xospata), which was approved by the FDA in 2018 for a type of leukemia, but has been shown to have activity against ALK NSCLC in patient-derived models (mice with transplanted human cancer).

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Clinical TrialsKirk SmithGilteritinib, Research
Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655
Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655

CAMBRIDGE, Mass., May 16, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to NVL-655 for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with two or more ALK tyrosine kinase inhibitors (TKIs).

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Clinical TrialsKirk SmithNuvalent, Research
The Global Landscape of Research: ALK-Positive Cancer Therapeutic Trials Worldwide
The Global Landscape of Research: ALK-Positive Cancer Therapeutic Trials Worldwide

In the ever-evolving arena of ALK-positive cancer therapies, clinical trials offer patients not only cutting-edge interventions but also a chance to contribute to the advancement of ALK cancer treatment. In examining international ALK cancer trials, we uncover both challenges and opportunities for those seeking innovative treatments beyond conventional options.

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Clinical TrialsKirk SmithClinical Trials
First two weeks on NVL-655 clinical trial: Field Research for the Clinical Trials Committee
First two weeks on NVL-655 clinical trial: Field Research for the Clinical Trials Committee

I started on the Phase II NVL-655 trial on March 1st, 2024, at UC Davis’s Sacramento campus, a seventy-five-mile ride from my house.  I had pre-registered with Dr. Jonathan Riess’s trial coordinator in December, sending records from my oncologist electronically, and answering a lot of questions.  They wanted a record of my initial cancer, and details on the mutations that came up with various progressions, along with all the dates.  The current mutational profile was most important to the doctor for qualification to participate.  My local oncologist knew Dr. Riess personally, which helped, I think, and having your oncologist touch base with a prospective trial-coordinating doctor can help open the door. 

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Clinical Trials, Patient Stories, ResearchKirk SmithNuvalent, Clinical Trials
Unlocking Hope: Navigating your Path to ALK-Positive Lung Cancer Clinical Trials
Unlocking Hope: Navigating your Path to ALK-Positive Lung Cancer Clinical Trials

Participating in a clinical trial can provide hope for those with ALK-positive lung cancer, offering a glimpse into the realm of cutting-edge treatments. Understanding eligibility criteria can be paramount for those seeking to participate in a clinical trial. Here we will highlight some of the opportunities and challenges of clinical trial eligibility

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Clinical TrialsKirk SmithClinical Trials
University of Michigan Biopsy and Organoid Drug Screening Experience
University of Michigan Biopsy and Organoid Drug Screening Experience

I’m writing this on the return flight from the University of Michigan, where I underwent a thoracic biopsy for three lymph nodes that have been lighting up in my recent PET scans.  As I am the ALK Positive patient advocate on the Judith Tam ALK NSCLC Research Initiative Scientific Advisory Board, l thought I’d do a trial run and see if going there for my biopsy and tissue testing would be worthwhile. 

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Clinical Trials, ResearchKirk SmithClinical Trials, Research, University of Michigan
ALINA Trial Unveils a Paradigm Shift in the Battle Against Early Stage, Resectable ALK-Positive Lung Cancer
ALINA Trial Unveils a Paradigm Shift in the Battle Against Early Stage, Resectable ALK-Positive Lung Cancer

One of the challenges in our community has been the treatment of earlier stages of ALK-positive lung cancer, including stages IA through 3A. Historically, we've faced a lack of definitive guidelines for addressing the illness that represents 30-40% of the total ALK lung cancer population. Patients in these stages are traditionally treated with surgical tumor removal, followed by platinum chemotherapy. This treatment is a "one size fits all" approach to earlier stage lung cancer, without concern for the presence of the ALK mutation.

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Clinical TrialsKirk SmithClinical Trials, ALINA study, Genentech, Dr. Ben Solomon
Unlocking Hope: Breakthroughs in ALK-Positive Cancer Research for All Ages
Unlocking Hope: Breakthroughs in ALK-Positive Cancer Research for All Ages

The spectrum of ALK-positive cancer knows no age limits. Meet the faces of courage: the ordinary individuals with the ALK-positive mutation. This mutation, notorious for lung cancer in adults, defies the stereotype. At just 52 years old, these fighters, who are usually non-smokers, shatter expectations. Yet, it doesn’t stop there – the youngest warriors, too, bear the burden of ALK-positive mutations. While a handful of kids battle ALK-positive lung cancer, an even greater number grapple with foes like lymphoma, sarcoma, and brain cancer, all stemming from the ALK-positive mutation.

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Clinical TrialsKirk SmithClinical Trials, Longitudinal Survey
Oncolytic Virus Research Collaboration: Memgen Inc., UMichigan, and ALK Positive, Inc.
Oncolytic Virus Research Collaboration: Memgen Inc., UMichigan, and ALK Positive, Inc.

The ALK Positive NSCLC Research Acceleration Committee (RAC) systematically reaches out to selected biotech companies with NSCLC treatments in development and/or trial.  In February of 2022, RAC member Ray Hall (father to patient Summer Farmen) wrote a letter to the CEO of Memgen Inc., introducing us and asking for a get-acquainted Zoom meeting, which occurred shortly thereafter.  CEO Greg Brown, MD, MBA, and Chief Scientific Officer Mark Cantwell, PhD let us know that they were initiating a clinical trial at Duke and Moffit Cancer Centers for their oncolytic virus drug MEM-288 for patients with solid tumors

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Research, Clinical TrialsKirk Smithresearch, Memgen, University of Michigan
Clinical Trials for ALK-positive Cancers - Are They for Me?
Clinical Trials for ALK-positive Cancers - Are They for Me?

The decision to enroll in a clinical trial requires a real understanding of what is being studied and how you will participate in the study. It is important to remember that clinical trials have been instrumental in developing all treatments for ALK-positive cancers. Many of our longest survivors have participated in clinical trials of treatments that are now the standard of care.

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Clinical TrialsKirk SmithClinical Trials
PATIENT SPOTLIGHT: Andrej Krivda, Wettingen, Switzerland
PATIENT SPOTLIGHT: Andrej Krivda, Wettingen, Switzerland

We interviewed fellow ALKie Andrej Krivda on his very interesting journey with ALK+ lung cancer and all the unexpected twists and turns he’s had to navigate since diagnosis. Andrej is the very first person to enter the Nuvalent NVL-655 clinical trial in Spain and one of the first patients to take part in the trial in all of Europe, and we were very interested in his perspective. He also happens to have a fascinating personal history. Enjoy the read!

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Patient Stories, Clinical TrialsKirk SmithPatient Spotlight, Clinical Trials, Nuvalent
You Can Find a Clinical Trial with the Help of ALK Positive
You Can Find a Clinical Trial with the Help of ALK Positive

At any juncture in treatment, those with ALK Positive cancers are faced with hard choices.  Whether you are first starting treatment or you are changing treatment due to progression or side effects, multiple options may be available. At these critical decision points, a clinical trial could be an excellent choice. You may trust your doctor to refer you to a clinical trial, but it is nearly impossible for any doctor to be aware of all the clinical trials that are available for ALK.

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Clinical TrialsKirk SmithClinical Trials
The New ALK Inhibitor: NVL-655 Trial Expands to Europe!
The New ALK Inhibitor: NVL-655 Trial Expands to Europe!

NVL-655 is a new experimental ALK inhibitor that is designed to treat ALK cancers, especially those that have become resistant to ALK inhibitors like lorlatinib, alectinib, and brigatinib. The study of this new drug is underway! Clinical trial sites in the U.S. include Orange, California; Denver, Colorado; Boston, Massachusetts; Detroit, Michigan; New York, New York; Nashville, Tennessee; and Seattle, Washington. The expansion to Europe includes sites in Toulouse Cedex, France; Villejuif, France; and Barcelona, Spain.

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Clinical Trials, ResearchKirk Smithresearch, Clinical Trials
Moderna’s Cancer Vaccine Program
Moderna’s Cancer Vaccine Program

Highly successful Covid vaccines have raised the question of ‘why not cancer vaccines?’, a question of great interest and financial contribution for the ALK Positive NSCLC community in recent years. Somewhat under the radar of our members is Moderna, Inc.’s multi-cancer clinical trial for their personalized mRNA vaccine that started in 2017. The trial is open to ALK NSCLC patients after progressing on TKIs, and it is based on the same platform as their approved Covid mRNA vaccine. It is currently in a multiple-arm Phase 1 trial and a randomized, fully enrolled Phase 2 trial.

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Research, Clinical TrialsKirk SmithClinical Trials, Moderna, Vaccine